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FDA 510(k) Application Details - K970684
Device Classification Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
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510(K) Number
K970684
Device Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Applicant
RANDOX LABORATORIES, LTD.
ARDMORE, DIAMOND ROAD
CRUMLIN BT29 4QY IE
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Contact
PONE ARMSTRONG
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Regulation Number
862.1440
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Classification Product Code
CFJ
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More FDA Info for this Product Code
Date Received
02/24/1997
Decision Date
05/07/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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